SPECTRON™ EFHip system

Surgical Technique

Surgical technique completed

in conjunction with

William W. Brien, M.D.

Associate Clinical Professor of Orthopaedic Surgery,

University of California at Irvine,

Irvine, California

Attending Surgeon, Cedars-Sinai Medical Center,

Los Angeles, California

J. Rod Davey, M.D., F.R.C.S.

Acting Head of Orthopaedic Surgery,

The Toronto Hospital

Assistant Professor of the Department of Surgery,

University of Toronto

Toronto, Ontario, Canada

Paul Di Cesare, M.D., F.A.C.S.

Hospital for Joint Diseases

Orthopaedic Institute

Director of Musculoskeletal Research Center

Co-Director of Surgical Arthritis Service

Assistant Professor of Orthopaedic Surgery,

New York University School of Medicine

New York, New York

Henrik Malchau, M.D., Ph.D.

Sahlgrenska University Hospital

Associate Professor

Department of Orthopaedics

Göteborg, Sweden

SPECTRON™ EFHip system

Nota Bene: The technique description herein is made available to the

healthcare professional to illustrate the authors’ suggested treatment

for the uncomplicated procedure.

In the final analysis, the preferred treatment is that which addresses the

needs of the patient.

Stem Specifications

SPECIFICATIONS

Size Neck Angle Distal Cross

Section

Stem Length A-P Width M-L Width

1, 1H 131º 6 mm 115 mm 12.9 mm 25.4 mm

2, 2H 131º 7 mm 125 mm 13.7 mm 27.2 mm

3, 3H 131º 8 mm 135 mm 14.5 mm 28.9 mm

4, 4H 131º 10 mm 135 mm 15.3 mm 30.7 mm

5, 5H 131º 12 mm 135 mm 16.1 mm 32.5 mm

NECK HEIGHT mmWhen Femoral Head Component Selected Is:

Cat. No. Size –3 +0 +4 +8 +12 +16

91-1390 1 24 26 28 31 34 36

91-1390 1H 24 26 28 31 34 36

91-1458 2 26 28 30 33 36 38

91-1390 2H 26 28 30 33 36 38

91-1457 3 28 30 32 35 37 40

91-1390 3H 28 30 32 35 37 40

91-0314 4 30 32 34 37 39 42

91-1390 4H 30 32 34 37 39 42

5 32 34 36 39 41 44

91-1390 5H 32 34 36 39 41 44

NECK OFFSET mmWhen Femoral Head Component Selected Is:

Cat. No. Size –3 +0 +4 +8 +12 +16

91-1390 1 32 35 38 41 44 47

91-1390 1H 38 41 44 47 50 53

91-1458 2 34 36 39 42 45 48

91-1390 2H 42 44 47 50 53 56

91-1457 3 35 38 41 44 47 50

91-1390 3H 45 48 51 54 57 60

91-0314 4 37 39 42 45 48 51

91-1390 4H 47 49 52 55 58 61

5 38 41 44 47 50 53

91-1390 5H 48 51 54 57 60 63

NECK LENGTH mmWhen Femoral Head Component Selected Is:

Cat. No. Size –3 +0 +4 +8 +12 +16

91-1390 1 27 30 34 38 42 46

91-1390 1H 31 34 38 42 46 50

91-1458 2 29 32 36 40 44 48

91-1390 2H 34 37 41 45 49 53

91-1457 3 31 34 38 42 46 50

91-1390 3H 37 40 44 48 52 56

91-0314 4 33 36 40 44 48 52

91-1390 4H 39 42 46 50 54 58

5 35 38 42 46 50 54

91-1390 5H 41 44 48 52 56 60

For use with Smith & Nephew 12/14 femoral heads only.

Standard Offset High Offset

NOT ACTUAL SIZE

-3 and +16 CoCr femoral

heads available in 28 mm and

32 mm only.

* Denotes skirted head

NOTE: For illustration purposes only. Surgi-

cal Templates are available by contacting

your Smith & Nephew Representative or

Customer Service.

Femoral Osteotomy

Femoral OsteotomyUse the osteotomy guide to determine the level of resec-

tion, using one of the following techniques:

A. Place the template over the X-ray of the hip. Determine the

stem size. Determine length of femoral head to be used.

A graduation scale can be found on the medial aspect of

the stem on the template. Make note of how many gradu-

ations above the lesser trochanter where the osteotomy

will take place, as determined by the collar of the stem.

In the O.R., place the osteotomy guide on the femur by

referencing the lesser trochanter at the same graduation

mark as noted during templating. Osteotomize the neck.

B. Place the template over the X-ray of the hip. Determine the

stem size. Determine length of femoral head to be used.

Determine the base neck length on the standard offset

stem as indicated on the template. Add to this number the

length of the femoral head.

In the O.R., place the greater trochanter block on the

osteotomy guide at this numerical position.

If the number does not match perfectly, use the lower

number. Place the guide on the femur by resting the block

on the top of the greater trochanter. Osteotomize the neck.

Prepare AcetabulumIf acetabular reconstruction is required, prepare acetabu-

lum using the technique for the intended acetabular

component.

1.

2.

Femoral Canal PreparationOpen the medullary canal at the transected neck using

the box chisel. Stay posterior and lateral in order

to obtain a neutral stem position (Figure 1). Sound the

femoral canal using the blunt medullary reamer (Figure 2).

Femoral Canal Preparation

3.

Figure 1 Figure 2

Femoral Broaching

Femoral BroachingStart the broaching procedure along the mid-axis of the

femur with the Size 1 broach and progressively broach to

the appropriate femoral stem size. Seat the broach slightly

below the level of the femoral neck resection to facilitate

calcar reaming.

The Spectron EF broach is designed to provide a minimum

1.5 mm cement mantle per side. Additional cement mantle

thickness is achieved by pressurizing the cement into the

cancellous bone. The broach is slightly longer than the

corresponding implant to accommodate the distal central-

izer.

4.

Calcar Preparation & Trialing

Calcar PreparationWith the final broach fully seated, remove the broach

handle and ream the calcar with the appropriate calcar

reamer. The smaller calcar reamer is used with broach

sizes 1–3, and the larger calcar reamer is used with broach

sizes 4 and 5. Plane the calcar until it is level with the

broach.

TrialingRemove the calcar reamer and place the matching stan-

dard or high offset trial neck (as determined by templat-

ing) onto the broach post. Select the trial femoral head

of desired diameter and neck length and reduce the hip

to assess stability. Soft tissue tension can be improved

by using the high offset trial neck instead of the standard

offset trial neck without increasing leg length.

If trialing for the universal Bipolar or Unipolar, trial accord-

ing to the appropriate technique for the selected device.

5.

6.Standard Offset High Offset

FEMORAL HEAD AND NECK LENGTH OPTIONS Trial Color 22 mm 26 mm 28 mm 32 mm

Green — — –3 –3

Yellow +0 +0 +0 +0

Red +4 +4 +4 +4

White +8 +8 +8 +8

Blue +12* +12* +12* +12*

Black — — +16* +16*

Placing The Buck™ Cement RestrictorAttach the broach handle to the broach and remove the

broach from the femoral canal. The proximal flange of the

cement restrictor should always be larger than the distal

canal diameter. Use the canal sizer to determine the distal

canal diameter. Accurate cement restrictor depth place-

ment is then determined by placing the Spectron EF stem

(with attached distal centralizer) next to the inserter tool

and adding 20 mm to the length (see chart below).

Remove the vent-occluding membrane by inserting

the vent opening tool into the distal end of the restrictor

and pushing the pin through the vent hole. Remove and

discard the plastic debris.

Thread the cement restrictor onto the inserter using

a clockwise motion. Insert the device to the level

of the medullary canal that has been predetermined.

Once this level is reached, disengage the restrictor from

the inserter using a counterclockwise twisting motion.

Remove the inserter from the medullary canal. If it is nec-

essary to remove the restrictor prior to cement insertion,

it can be reattached to the inserter rod and pulled out of

the canal. The surgeon may adjust the restrictor as many

times as required.

Placing The Buck™ Cement Restrictor

7.

STEM SIZEBUCK CEMENT RESTRICTOR

INSERTION DEPTH (MM)1 1402 1503 1604 1605 160

Preparing The Femoral Canal

8.

9.

Preparing The Femoral CanalIrrigate the canal with saline solution and pulsatile

lavage to remove all debris. Continue preparing

the femur with the femoral canal brush to remove any

remaining weak cancellous bone, blood clots, and

marrow fats. Repeat lavaging as necessary to

remove all remaining debris.

Drying The Femoral CanalInsert the femoral canal suction absorber into the femoral

canal to dry the canal while mixing the cement.

Injecting Cement

10. Loading CementLoad cement powder and

monomer into the MixOR™

funnel. If you load powder first,

use the funnel for both. If you

prefer monomer first, load mono-

mer without funnel, then attach and

load powder.

Mixing Mix the cement according to

manufacturer’s instructions us-

ing brisk plunging movements.

Turn handle at top and bottom

of cartridge to achieve optimal

homogenous mixture. Refer

to MixOR instruction card for

complete mixing technique.

Injecting CementAfter removing the femoral canal suction absorber, use

pulsatile lavage. Insert the nozzle of the cement gun to the

top of the Buck cement restrictor and inject cement into

the canal in retrograde fashion.

Continue injecting cement until the canal is completely full

and the distal tip of the nozzle is clear of the canal.

11.

12.

Pressurizing Cement

13. Pressurizing CementBreak off the long nozzle and place the femoral pressur-

izer over the short nozzle. Apply the disposable femoral

pressurizer into the mouth of the canal. This will oc-

clude the canal and compress the cement. Maintain firm

pressure until the cement is in a doughy state and can

withstand displacement and will allow for proper cement

interdigitation into trabecular bone. Withdraw the femoral

pressurizer and remove any extruded cement around the

periphery of the canal.

Selecting Stem & Distal Centralizer

14. Selecting Stem & Distal CentralizerUse the implant which corresponds to the last broach

seated in the femur. An optional distal centralizer may be

placed on the stem to provide neutral alignment and pre-

dictable cement mantle. Each implant has a corresponding

distal centralizer which is intended to provide a uniform 1.5

mm distal cement mantle. Note, however, all of the stems

will accommodate any of the available distal centralizers

to address variations in distal femoral geometries. Using

clean gloves, place the round plug of the selected cen-

tralizer into the hole at the distal end of the stem and push

the centralizer superiorly until snug.

NOTE: If a distal centralizer is not used, place the distal

hole plug which is packaged with the implant into the

centralizer hole prior to inserting the stem.

STEM SIZE MINIMUM CENTRALIZER SIZESizes 1, 1H 8 mmSizes 2, 2H 9 mmSizes 3, 3H 10 mmSizes 4, 4H 12 mmSizes 5, 5H 13 mm

Stem Insertion

15. Stem InsertionInsert the selected femoral stem into the canal. Fit the

femoral stem driver into the stem driving platform and

push into place. Advance the stem approximately 1 cm

per second to avoid air inclusions in the stem/cement

interface.

Trim away excess cement with Concise™ cement sculps.

Remove the stem driver and maintain steady pressure

with the thumb on the neck taper until cement is cured.

Final Trial ReductionA final trial reduction may be performed at this time using

trial femoral heads.

16.

Femoral Head Assembly

17. Femoral Head AssemblyClean and dry the neck taper with a clean sterile cloth.

Place the prosthetic femoral head on the neck taper and

firmly impact several times with a head impactor and a

mallet.

20 mm

SPECTRON EF 12/14 FEMORAL STEM

Catalog Information

SizeStem

LengthImplantCat. No.

Broach/Trial Cat. No.

Trial NeckCat. No.

1 115 mm 7131-2101 7136-5001 7136-5081

2 125 mm 7131-2102 7136-5002 7136-5082

3 135 mm 7131-2103 7136-5003 7136-5083

4 135 mm 7131-2104 7136-5004 7136-5084

5 135 mm 7131-2105 7136-5005 7136-5085

SizeStem

LengthImplantCat. No.

Broach/Trial Cat. No.

Trial NeckCat. No.

1H 115 mm 7131-2111 7136-5001 7136-5091

2H 125 mm 7131-2112 7136-5002 7136-5092

3H 135 mm 7131-2113 7136-5003 7136-5093

4H 135 mm 7131-2114 7136-5004 7136-5094

5H 135 mm 7131-2115 7136-5005 7136-5095

Spectron EF 12/14 Primary Collared StemsCobalt Chromium – ASTM F 799

Spectron EF 12/14 Primary High Offset StemsCobalt Chromium – ASTM F 799

Spectron Invis™ Distal Centralizers

Invis™ Distal Centralizers

Cat. No. Size O. D.7131-3101 1 8 mm

7131-3102 2 9 mm

7131-3103 3 10 mm

7131-3104 4 12 mm

7131-3105 5 13 mm

Cat. No. O.D.7131-3208 8 mm7131-3209 9 mm7131-3210 10 mm7131-3211 11 mm7131-3212 12 mm7131-3213 13 mm7131-3214 14 mm

Cat. No. O.D.7131-3215 15 mm7131-3216 16 mm7131-3217 17 mm7131-3218 18 mm7131-3219 19 mm7131-3220 20 mm7131-3221 21 mm

HEAD COMPONENTS

Catalog Information

OXINIUM™ Femoral Heads 12/14 Taper

Neck Length 28mm 32mm+0 (short) 71330280 71330320

+4 (medium) 71330284 71330324+8 (long) 71330288 71330328

Alumina Ceramic Femoral Heads 12/14 Taper

Neck Length 22mm 26mm 28mm 32mm-3 —— —— 71302803 71303203+0 71302200 71302600 71302800 71303200+4 71302204 71302604 71302804 71303204+8 71302208 71302608 71302808 71303208+12 71302212 71302612 71302812 71303212+16 —— —— 71302816 71303216

CoCr Femoral Heads 12/14 TaperCobalt Chromium - ASTM F 799

Neck Length 28mm 32mm 36mm-3 71342803 71343203 71343603+0 71342800 71343200 71343600+4 71342804 71343204 71343604+8 71342808 71343208 71343608+12 71342812 71343212 71343612+16 71342816 71343216 ——

SPECTRON EF 12/14 INSTRUMENTATION

Catalog Information

12/14 Dual Offset Sterilization TrayCat. No. 7136-9112

12/14 Standard Offset Sterilization Tray(Not Shown)

Cat. No. 7136-9113

Osteotomy GuideCat. No. Size

7136-5036 Sizes 1–5

Box ChiselCat. No. Size

7136-4002 Small

Blunt Medullary ReamerCat. No. 11-9657

Broach HandleCat. No. 7136-4007

Anteversion HandleCat. No. 7136-4012

Broaches/Trials

Cat. No. Size

7136-5001 Size 1

7136-5002 Size 2

7136-5003 Size 3

7136-5004 Size 4

7136-5005 Size 5

SPECTRON EF 12/14 INSTRUMENTATION

Catalog Information

Trial 12/14 Taper Femoral Heads

Cat. No. Size7136-5023 Size 1–37136-5025 Size 4–5

Size

Primary CollaredCat. No.

Size

Primary High Offset

Cat. No. 1 7136-5081 1H 7136-5091 2 7136-5082 2H 7136-5092 3 7136-5083 3H 7136-5093 4 7136-5084 4H 7136-5094 5 7136-5085 5H 7136-5095

Neck Length Color Code 22 mm *26 mm *28 mm 32 mm–3 Green — — 7135-2803 7135-3203+0 Yellow 7135-2200 7135-2600 7135-2800 7135-3200+4 Red 7135-2204 7135-2604 7135-2804 7135-3204+8 White 7135-2208 7135-2608 7135-2808 7135-3208+12 Blue 7135-2212 7135-2612 7135-2812 7135-3212+16 Black — — 7135-2816 7135-3216

Calcar Reamers

12/14 Taper Trial Necks

Femoral Component DriverCat. No. 11-9817

Femoral Head ImpactorCat. No. 11-9817

*Space allowed for 26 mm and 28 mm heads in instrument tray.

ADDITIONAL SPECTRON EF 12/14 INSTRUMENTATION

Catalog Information

Box ChiselCat. No. Size

7136-4003 Large

Slotted HammerCat. No. MT-1901

Femoral Head Removal Tool

Cat. No. 11-9683

Includes:

Pry Tool—Thin

Platform—Left

Pry Tool—Thick

Platform—Right

Femoral Component ExtractorCat. No. 11-9871

Side Angled CuretteCat. No. Size

11-9672 Right

11-9673 Left

Dead Blow MalletCat. No. 7136-2106

Canal SizerCat. No. 7136-7301

CEMENT & ACCESSORIES

Catalog Information

PREP-IM® KitCat. No. 12-1000

Kit contains the following:

Cat. No. Description

12-9418 Buck Cement Restrictor, 18.5 mm

12-9419 Buck Cement Restrictor, 25 mm

11-0003 Femoral Canal Brush, 19 mm

11-1000 Concise Cement Sculps Kit

11-0037 Femoral Canal Suction Absorber, 19 mm

— Disposable Cement Restrictor Tool

(Available in kit only)

Vent Opening ToolCat. No. 11-0028

Buck Cement RestrictorCat. No. Size

12-9418 18.5 mm

12-9419 25 mm

7127-9420 30 mm

7127-9421 35 mm

Concise Cement Sculps KitCat. No. 11-1000

(one of each)

Femoral Canal Suction AbsorberCat. No. Size

11-0037 19 mm

11-0038 25 mm

Buck Femoral Cement Restrictor Inserter Cat. No. 11-2428

Femoral Canal BrushCat. No. O.D.

11-0003 19 mm

11-0033 12.5 mm

MixOR™ Vacuum Mixing System with SyringeCat. No. 7127-0020

Femoral PressurizersCat. No. Size

7127-0026 Small

7127-0027 Medium

7127-0028 Large

CEMENT & ACCESSORIES

Catalog Information

Femoral Cement CompressorCat. No. 11-1434

Disposable Femoral CementCompressor CapCat. No. 11-1435

MixOR Pump and Hose KitCat. No. 7127-0040

MixOR Hose Only (not shown)

Cat. No. 7127-0041

MixOR Pump Only

(not shown)

Cat. No. 7127-0042

InjectOR Gun

Cat. No. 7127-2000

Connector, SchraederCat. No. 7127-0050

Connector, DragerCat. No. 7127-0051

Connector, D.I.S.S.Cat. No. 7127-0052

IMPORTANT NOTETotal hip replacement arthroplasty has become a successful procedure for relieving pain and restoring motion in patients who are disabled from hip arthropathy. The goals of total hip re-placement are to decrease pain, increase function, and increase mobility.

MATERIALSThe Total Hip System is manufactured from materials as outlined below. The component mate-rial is provided on the outside carton label.

Component Material Material Standards

Femoral Components Ti-6Al-4V ASTM F 136 and ISO 5832/3 or or ASTM F 1472 and ISO 5832/3 Co-Cr-Mo or ASTM F 799 and ISO 5832/12 or ASTM F 75 and ISO 5832/4Acetabular shells Ti-6Al-4V ASTM F 1472 and ISO 5832/3Proximal padsTaper sleevesDistal sleevesFixation screws and pegsHole coversAcetabular components UHMWPE ASTM F 648Acetabular linersFemoral centralizers PMMA Not applicableAcetabular spacer podsX-ray marking wire Co-Cr-Mo ASTM F 90 and ISO 5832/5Acetabular CP Titanium ASTM F 67 and ISO 5832/2Reconstruction RingAcetabularReinforcement RingFemoral Heads Co-Cr-Mo ASTM F 799 and ISO 5832/12 Zirconia ISO 13356 Ceramic

Porous titanium components and porous Co-Cr-Mo components are coated with commercially pure (C.P.) titanium beads (ASTM F 67 and ISO 5832/2) and Co-Cr-Mo beads (ASTM F 75), respectively. Hydroxylapatite coatings include HA (ASTM F 1185) that is applied either on a grit blasted or porous surface. NOTE: HA coated porous implants are not available in the USA.

Zirconia ceramic femoral heads are yttria stabilized zirconia ceramic.

Some of the alloys needed to produce orthopedic implants contain some metallic components that may be carcinogenic in tissue cultures or intact organism under very unique circumstances. Questions have been raised in the scientific literature as to whether or not these alloys may be carcinogenic in implant recipients. Studies conducted to evaluate this issue have not identified conclusive evidence of such phenomenon, in spite of the millions of implants in use.

DESCRIPTION OF SYSTEMThe Total Hip System consists of femoral components, proximal pads, taper sleeves, distal sleeves, acetabular components, fixation screws and pegs, hole covers, centralizers, and femo-ral heads. Components may be grit blasted, porous coated, hydroxylapatite (HA) coated, or HA porous coated. All implantable devices are designed for single use only.

Femoral ComponentsFemoral components are available in a variety of sizes. Porous coated components are coated for biological ingrowth. Proximally and distally modular femoral components accept proximal pads and distal sleeves, respectively. Non-porous femoral components can feature PMMA cen-tralizers that help produce a uniform thickness of cement in a concentric manner.

Femoral components are available with a small, large (14/16), or 12/14 global taper (gage diam-eters 0.404, 0.564, and 0.500 inches, respectively).

Small taper femoral components mate and lock directly with a 22 mm metal or ceramic head. The small taper also mates with a taper sleeve which, in turn, mates with either metal or ceramic heads (26, 28, or 32 mm), bipolar or unipolar components.

Large taper femoral components mate and lock with either metal heads (26, 28, or 32 mm), ceramic heads (22, 28 or 32 mm), bipolar or unipolar components. Femoral components with a 12/14 taper mate and lock with either metal heads (22, 26, 28, or 32 mm), ceramic heads (26 or 28 mm), bipolar or unipolar components. Small, large, and 12/14 taper femoral component tapers are machined to mate and lock with ceramic heads, thus preventing rotation of the ceramic head on the stem, the latter would cause wear of the stem taper.

Taper SleevesA taper sleeve is required to be impacted on the small taper femoral component prior to impact-ing a femoral head size 26, 28, or 32 mm. A taper sleeve is required to attach a unipolar head. Unipolar taper sleeves are available in small, large, and 12/14 tapers. Never place more than one taper sleeve on a femoral component.

Femoral HeadsCobalt chromium (22, 26, 28, and 32 mm) and ceramic (22, 26, 28, and 32 mm) heads are available in multiple neck lengths for proper anatomic and musculature fit. Heads are highly polished for reduced friction and wear. The following zirconia ceramic heads are available for use only with small (0.404) and large (.564) taper femoral components.

Zirconia Head Ceramic Diameter Neck Length 42-7815 32 mm Standard 0 mm 42-7816 32 mm Long 4 mm 42-7817 32 mm X-Long 8 mm 42-7818 28 mm Standard 0 mm 42-7819 28 mm Long 4 mm 42-7820 28 mm X-Long 8 mm

Note: 32 mm heads with a -3 mm neck length are not available for use with the small taper stems.

In addition to the components listed above, the following components are available for use only with small (0.404) taper femoral components

Zirconia Head Ceramic Diameter Neck Length 7132-0002 22 mm Long 4 mm 7132-0006 22 mm X-Long 8 mm

Note: 22 mm Zirconia Ceramic Heads used with small (0.404) taper femoral components are not available in the USA.

The following zirconia ceramic heads are available for use only with 12/14 taper femoral com-ponents:

Zirconia Head Ceramic Diameter Neck Length 7132-0028 28 mm Standard 0 mm 7132-0428 28 mm Long 4 mm 7132-0828 28 mm X-Long 8 mm 7132-0026 26 mm Standard 0 mm 7132-0426 26 mm Long 4 mm 7132-0826 26 mm X-Long 8 mm 7132-0422 22 mm Long 4 mm 7132-0822 22 mm X-Long 8 mm

Acetabular ComponentsAcetabular components can be one piece all polyethylene or two-piece components consisting of a titanium shell and a polyethylene liner. Please see Warnings and Precautions for specific information on screws, pegs and hole covers use. Acetabular reinforcement and reconstruction rings are used with an all polyethylene acetabular component.

Femoral components and femoral heads are designed for use with any Smith & Nephew poly-ethylene acetabular component or polyethylene-lined, metal-backed acetabular component having an appropriately-sized inside diameter.

INDICATIONS, CONTRAINDICATIONS, AND ADVERSE EFFECTSHip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of os-teoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.

Hip components are also indicated for inflammatory degenerative joint disease including rheu-matoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; old, remote osteomyelitis with an extended drainage-free period, in which case, the patient should be warned of an above normal danger of infection postoperatively; treatments of nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with heads in-volvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture-dislocation of the hip; and correction of deformity.

IMPORTANT MEDICAL INFORMATIONWarnings and PrecautionsTotal Hip System

Acetabular reinforcement and reconstruction rings are intended to be used in primary and revision surgeries where the acetabulum has the deficiencies of the acetabular roof, anterior or posterior pillar, medial wall deficiency, and / or protrusion as a result of the indications listed previously.

Some of the diagnoses listed above and below may also increase the chance of complications and reduce the chance of a satisfactory result.

Contraindications1. Conditions that would eliminate or tend to eliminate adequate implant support or prevent

the use of an appropriately-sized implant, e.g.: a. blood supply limitations; b. insufficient quantity or quality of bone support, e.g., osteoporosis, or metabolic disor-

ders which may impair bone formation, and osteomalacia; and c. infections or other conditions which lead to increased bone resorption.

2. Mental or neurological conditions which tend to impair the patient’s ability or willingness to restrict activities.

3. Physical conditions or activities which tend to place extreme loads on implants, e.g., Char-cot joints, muscle deficiencies, multiple joint disabilities, etc.

4. Skeletal immaturity.

5. The zirconia ceramic head is contraindicated for use with any other product than an UHMW polyethylene cup or a metal backed UHMW polyethylene cup.

Contraindications may be relative or absolute and must be carefully weighted against the patient’s entire evaluation and the prognosis for possible alternative procedures such as non-operative treatment, arthrodesis, femoral osteotomy, pelvic osteotomy, resection arthroplasty, hemiarthroplasty and others.

Conditions presenting increased risk of failure include: osteoporosis, metabolic disorders which may impair bone formation, and osteomalacia.

Possible Adverse Effects1. Wear of the polyethylene articulating surfaces of acetabular components has been report-

ed following total hip replacement. Higher rates of wear may be initiated by the presence of particles of cement, metal, or other debris which can develop during or as a result of the surgical procedure and cause abrasion of the articulating surfaces. Higher rates of wear may shorten the useful life of the prosthesis, and lead to early revision surgery to replace the worn prosthetic components.

2. With all joint replacements, asymptomatic, localized, progressive bone resorption (oste-olysis) may occur around the prosthetic components as a consequence of foreign-body reaction to particulate wear debris. Particles are generated by interaction between compo-nents, as well as between the components and bone, primarily through wear mechanisms of adhesion, abrasion, and fatigue. Secondarily, particles may also be generated by third-body particles lodged in the polyethylene articular surface. Osteolysis can lead to future complications necessitating the removal or replacement of prosthetic components.

3. Loosening, bending, cracking, or fracture of implant components may result from failure to observe the Warnings and Precautions below. Fracture of the implant can occur as a result of trauma, strenuous activity, improper alignment, or duration of service.

4. Dislocations, subluxation, decreased range of motion, or lengthening or shortening of the femur caused by improper neck selection, positioning, looseness of acetabular or femoral components, extraneous bone, penetration of the femoral prosthesis through the shaft of the femur, fracture of the acetabulum, intrapelvic protrusion of acetabular component, femoral impingement, periarticular calcification, and/or excessive reaming.

5. Fracture of the pelvis or femur: post-operative pelvic fractures are usually stress fractures. Femoral fractures are often caused by defects in the femoral cortex due to misdirected reaming, etc. Intraoperative fractures are usually associated with old congenital deformity, improper stem selection, improper broaching, and/or severe osteoporosis.

6. Infection, both acute post-operative wound infection and late deep wound sepsis.

7. Neuropathies; femoral, sciatic, peroneal nerve, and lateral femoral cutaneous neuropathies have been reported. Temporary or permanent nerve damage resulting in pain or numb-ness of the affected limb.

8. Wound hematoma, thromboembolic disease including venous thrombosis, pulmonary em-bolus, or myocardial infarction.

9. Myositis ossificans, especially in males with hypertrophic arthritis, limited pre-operative range of motion and/or previous myositis. Also, periarticular calcification with or without impediment to joint mobility can cause decreased range of motion.

10. Trochanteric nonunion usually associated with early weight bearing and/or improper fixa-tion of the trochanter, when a transtrochanteric surgical approach is used.

11. Although rare, metal sensitivity reactions and/or allergic reactions to foreign materials have been reported in patients following joint replacement.

12. Damage to blood vessels.

13. Traumatic arthrosis of the knee from intraoperative positioning of the extremity.

14. Delayed wound healing.

15. Aggravated problems of the affected limb or contralateral extremity caused by leg length discrepancy, excess femoral medialization, or muscle deficiency.

16. Failure of the porous coating/ substrate interface or hydroxylapatite coating/ porous coat-ing bonding may result in bead separation delamination.

17. Stem migration or subsidence has occurred in conjunction with compaction grafting pro-cedures usually resulting from insufficient graft material or improper cement techniques. Varus stem alignment may also be responsible.

WARNINGS AND PRECAUTIONSThe patient should be warned of surgical risks, and made aware of possible adverse effects. The patient should be warned that the device does not replace normal healthy bone, that the implant can break or become damaged as a result of strenuous activity or trauma, and that it has a finite expected service life and may need to be replaced in the future. Do not mix com-ponents from different manufacturers. Additional Warnings and Precautions may be included in component literature.

Preoperative1. Use extreme care in handling and storage of implant components. Cutting, bending, or

scratching the surface of components can significantly reduce the strength, fatigue re-sistance, and/or wear characteristics of the implant system. These, in turn, may induce internal stresses that are not obvious to the eye and may lead to fracture of the component. Implants and instruments should be protected from corrosive environments such as salt air during storage. Do not allow the porous surfaces to come in contact with cloth or other fiber-releasing materials.

2. Allergies and other reactions to device materials, although infrequent, should be consid-ered, tested for (if appropriate), and ruled out preoperatively.

3. Fixation and expected longevity of components expected to be left in place at revision surgery should be thoroughly assessed.

4. Surgical technique information is available upon request. The surgeon should be familiar with the technique.

5. Intraoperative fracture or breaking of instruments can occur. Instruments which have expe-rienced extensive use or excessive force are susceptible to fracture. Instruments should be examined for wear, or damage, prior to surgery.

6. Do not cold water quench ceramic components and never sterilize ceramic heads while fixed on the stem taper. (See sterilization section, below.)

7. Select components such that the Zirconia ceramic head always articulates with a UHMW polyethylene cup or a metal backed UHMW polyethylene cup. Zirconia ceramic should never articulate against metal because severe wear of the metal will occur.

8. Select only Smith & Nephew femoral components that indicate their use with ceramic heads. This is important because the taper on the stem is machined to tightly mate and lock with the ceramic head thus preventing rotation of the ceramic head on the stem. Also, an improperly dimensioned taper could result in fracture of the ceramic head.

9. The zirconia ceramic head is composed of a new ceramic material with limited clinical history. Although mechanical testing demonstrates that when used with a polyethylene acetabular component, the yttria stabilized zirconia ball produces a relatively low amount of particulates, the total amount of particulate remains undetermined. Because of the lim-ited clinical and preclinical experience, the biological effect of these particulates can not be predicted.

Intraoperative1. The general principles of patient selection and sound surgical judgment apply. The correct

selection of the implant is extremely important. The appropriate type and size should be selected for patients with consideration of anatomical and biomechanical factors such as patient age and activity levels, weight, bone and muscle conditions, any prior surgery and anticipated future surgeries, etc. Generally, the largest cross-section component which will allow adequate bone support to be maintained is preferred. Failure to use the optimum-sized component may result in loosening, bending, cracking, or fracture of the component and/or bone.

2. Correct selection of the neck length and cup, and stem positioning, are important. Muscle looseness and/or malpositioning of components may result in loosening, subluxation, dislocation, and/or fracture of components. Increased neck length and varus positioning will increase stresses which must be borne by the stem. The component should be firmly seated with the component insertion instruments.

3. Care should be taken not to scratch, bend (with the exception of the Reconstruction Rings) or cut metal components during surgery for the reasons stated in Number One of the “Preoperative” section of “Warnings and Precautions.”

4. A +12 mm or +16 mm femoral head should not be used with any small taper stems.

5. Distal sleeves should not be used to bridge cortical defects that lie within 25 mm of the tip of the base stem.

6. Matrix small taper stem sizes 8S–10L must have a minimum neck length of +8 mm when used with a bipolar component; and small taper stem sizes 12S–16L must have a minimum neck length of +4 mm when used with a bipolar component.

7. Modular heads and femoral components should be from the same manufacturer to pre-vent mismatch of tapers.

8. Clean and dry stem taper prior to impacting the femoral head or taper sleeve. The modular femoral head component must be firmly seated on the femoral component to prevent dis-association.

9. Take care, when positioning and drilling screw and peg holes, to avoid penetration of the inner cortex of the pelvis, penetration of the sciatic notch, or damage to vital neurovascular structures. Perforation of the pelvis with screws that are too long can rupture blood vessels causing the patient to hemorrage. Do not place a screw in the center hole of the acetabular prosthesis.

Placement of drills and screws in the anterior or medial portions of the prosthesis is as-sociated with a high risk of potentially fatal vascular injury.

Bone screws must be completely seated in the holes of the shell to allow proper locking for the acetabular component liner. If the tapered pegs need to be removed from the shell after impaction of the pegs, do not reuse the pegs or the peg shell holes. Use new pegs and different shell holes, or a new shell if necessary.

10. USE ONLY REFLECTION® TITANIUM BONE SCREWS, UNIVERSAL CANCELLOUS BONE SCREWS, TAPERED PEGS, AND HOLE COVERS with the Reflection Acetabular Component and USE ONLY OPTI-FIX® TITANIUM BONE SCREWS AND UNIVERSAL CANCELLOUS BONE SCREWS with the Opti-Fix Acetabular Component. The Reflection Interfit and the Reflection For Screws Only (FSO) shells accept Universal Cancellous, Reflection screws, and tapered screw-hole covers, not pegs. Tapered pegs can only be used with Reflection V Shells. The threaded center hole in Reflection Shells only accepts the threaded hole cover, not screws or pegs. The InterFit threaded hole cover is only for use with Reflection Interfit. The Reflection threaded hole cover can be used with both Reflection and InterFit shells. Refer to product literature for proper adjunctive fixation and hole cover usage.

11. Prior to seating modular components, surgical debris including tissue must be cleaned from the surfaces. Debris, including bone cement, may inhibit the component locking mechanism. If the shell is to be cemented in place, remove extraneous cement with a plas-tic sculps tool to ensure proper locking of the liner. During liner insertion, make sure soft tissue does not interfere with the shell/liner interface. Chilling the liner reduces the impac-tion force required to seat the liner. Modular components must be assembled securely to prevent disassociation. Debris inhibits the proper fit and locking of modular components which may lead to early failure of the procedure. Failure to properly seat the acetabular liner into the shell can lead to disassociation of the liner from the shell.

12. Avoid repeated assembly and disassembly of the modular components which could com-promise the critical locking action of the locking mechanism.

13. Care is to be taken to assure complete support of all parts of the device embedded in bone cement to prevent stress concentration which may lead to failure of the procedure. During curing of the cement, care should be taken to prevent movement of the implant components.

14. If components are to be left in place at revision surgery, they should first be thoroughly checked for signs of looseness, etc. and replaced if necessary. The head/neck component should be changed only when clinically necessary.

15. Once removed from the patient, implants previously implanted should never be reused, since internal stresses which are not visible may lead to early bending or fracture of these components.

16. With the congenitally dislocated hip, special care should be taken to prevent sciatic nerve palsy. Also, note that the femoral canal is often very small and straight and may require an extra-small straight femoral prosthesis; however, a regular-sized prosthesis should be used when possible. Note that the true acetabulum is rudimentary and shallow. A false acetabulum should not ordinarily be utilized as a cup placement site for anatomical and biomechanical reasons.

17. With rheumatoid arthritis, especially for those patients on steroids, bone may be extremely osteoporotic. Care should be taken to prevent excessive penetration of the acetabular floor or fracture of the medial acetabular wall, femur, or greater trochanter.

18. Revision procedures for previous arthroplasty, Girdlestone, etc., are technically demanding and difficult to exercise. Common errors include misplacement of the incision, inadequate exposure or mobilization of the femur, inadequate removal of ectopic bone, or improper positioning of components. Postoperative instability as well as excessive blood loss can re-sult. In summary, increased operative time, blood loss, increased incidence of pulmonary embolus and wound hematoma can be expected with revision procedures.

19. Prior to closure, the surgical site should be thoroughly cleaned of cement, bone chips, ectopic bone, etc. Ectopic bone and/or bone spurs may lead to dislocation or painful or restricted motion. Range of motion should be thoroughly checked for early contact or in-stability.

Postoperative1. Postoperative directions and warnings to patients by physicians, and patient care, are ex-

tremely important. Gradual weight bearing is begun after surgery in ordinary total hip ar-throplasty. However, with trochanter osteotomy or certain complex cases, weight-bearing status should be individualized with the non or partial weight-bearing period extended.

2. Patients should be warned against unassisted activity, particularly use of toilet facilities and other activities requiring excessive motion of the hip.

3. Use extreme care in patient handling. Support should be provided to the operative leg when moving the patient. While placing the patient on bedpans, changing dressings, and clothing, and similar activities, precautions should be taken to avoid placing excessive load on the operative part of the body.

4. Postoperative therapy should be structured to regain muscle strength around the hip and a gradual increase of activities.

5. Periodic x-rays are recommended for close comparison with immediate postoperative conditions to detect long-term evidence of changes in position, loosening, bending and/or cracking of components or bone loss. With evidence of these conditions, patients should be closely observed, the possibilities of further deterioration evaluated, and the benefits of early revision considered.

6. Prophylactic antibiotics should be recommended to the patient similar to those suggested by the American Heart Association for conditions or situations that may result in bactere-mia.

PACKAGING AND LABELING

Components should only be accepted if received by the hospital or surgeon with the factory packaging and labeling intact.

STERILIZATION/RESTERILIZATION

Most implants are supplied sterile and have been packaged in protective trays. The method

of sterilization is noted on the package label. All radiation sterilized components have been exposed to a minimum of 25 kilo Grays of gamma radiation. If not specifically labeled sterile, the implants and instruments are supplied non-sterile and must be sterilized prior to use. Inspect packages for punctures or other damage prior to surgery.

Metal ComponentsNonporous metal components may be initially sterilized or resterilized, if necessary, by steam autoclaving in appropriate protective wrapping, after removal of all original packaging and la-beling. Protect the devices, particularly mating surfaces, from contact with metal or other hard objects which could damage the product. The following process parameters are recommended for these devices:

∑ Prevacuum Cycle: 4 pulses (Maximum = 26.0 psig [2.8 bars] & Minimum = 10.0 inHg [339 millibars]) with a minimum dwell time of 4 minutes at 270°F to 275°F (132°C to 135°C), fol-lowed by a 1 minute purge and at least 15 minutes of vacuum drying at 10 inHg (339 millibars) minimum.

∑ Gravity Cycle: 270°F to 275°F (132°C to 135°C) with a minimum dwell time at temperature of 15 minutes, followed by a 1 minute purge and at least 15 minutes of vacuum drying at 10 inHg (339 millibars) minimum.

Smith & Nephew does not recommend the use of low temperature gravity cycles or flash ster-ilization on implants.

Do not resterilize femoral prostheses with ceramic heads seated on the stem.

If porous coated implants are inadvertently contaminated, return the unsoiled prosthesis to Smith & Nephew for resterilization. DO NOT RESTERILIZE porous coated implants. The porous coating requires special cleaning procedures.

Plastic ComponentsPlastic components may be resterilized by ethylene oxide gas. The following parameters are recommended as starting points for cycle validation by the health care facility:

Sterilant Temp. HumidityMaximumPressure

ConcentrationExposureTime

10% EtO90% HCFC

130˚F(55˚C)

40-60%28 PSIA(1930 millibar)

550-650mg/L

120minutes

10% EtO90% HCFC

100˚F(38˚C)

40-60%28 PSIA(1930 millibar)

550-650mg/L

6hours

100% EtO131˚F (55˚C)

30-60%10 PSIA(689 millibar)

736mg/L

30minutes

Suggested initial starting point for aeration validation is 12 hours at 122˚F (50˚C) with power aeration. Consult aerator manufacturer for more specific instructions.

Ceramic ComponentsDo not resterilize ceramic femoral heads.

INFORMATIONFor further information, please contact Customer Service at (800) 238-7538 for calls within the continental USA and (901) 396-2121 for all international calls.

Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician.

The degree of hypotension observed appears to be more marked in patients with elevated or high normal blood pressure, in hypovolemic conditions and in individuals with preexisting cardiovascular abnormalities. The duration of the hypotensive reaction may begin 10–165 seconds after insertion of both cement and prosthesis and may last up to 5–10 minutes.Introduction of liquid cement under pressure into a clean medullary canal has been shown to appreciably enhance the filling of the bone cavities with marked improvement in the security of the bone-cement interface. Care must be exercised in introducing the cement continuously from distal to proximal to avoid laminations in the cement.

CAUTIONFederal law restricts this device to sale, distribution, and use by or on the order of a physician.Manufactured by Heraeus Kulzer GmbH, Kulzer Division6393 Wehrheim, Federal Republic of Germany

Under license from E. Merck, Darmstadt, F.R. of GermanyPalacos is a trademark of Heraeus Kulzer GmbH.

Distributed by:In Canada, Richards Surgical LimitedSmith & Nephew Richards Inc. 7666 Bath Road1450 Brooks Road Mississauga, OntarioMemphis, Tennessee 38116 L4T1L2(901) 396-2121 (416) 677-9744Call Toll Free: 1-800-238-7538

Under the license ofE. Merck, DarmstadtFed. Rep. of Germany

*FOR MORE COMPLETE AND DETAILED DESCRIPTION, REFER TO PACKAGE INSERT SUPPLIED WITH THE PRODUCT.

Smith & Nephew, Inc. • 1450 Brooks Road • Memphis, TN 38116 U.S.A.(901) 396-2121 • For information: 1-800-821-5700 • For orders and order inquiries: 1-800-238-7538

Spectron, Buck, Concise, MATRIX, Reflection, MixOR, Invis, Opti-Fix and PREP-IM are trade-marks of Smith & Nephew, Inc. Palacos and Osteopal are registered trademarks of Hereaus Kulzer GmbH. U.S. Patent Description 381,084 ©1997 Smith & Nephew, Inc. 3/99 7138-0478